The objectives of the CPCRA Clinical Trials Unit (Community Programs for Clinical Research on AIDS) are: to conduct clinically relevant research in the prevention and treatment of HIV disease and its complications;to involve in clinical trials a demographically, geographically, and socio-economically diverse population of individuals infected with HIV or at risk of infection;and to carry out this research agenda in close collaboration with community members who are themselves infected with or affected by HIV. The CPCRA CTU will make significant contributions to the INSIGHT and HIV Prevention Trials (HPTN) networks, both in enrollment and in scientific expertise. Through INSIGHT, the CPCRA CTU will contribute to multiple, randomized clinical trials in order to help determine the optimal clinical management for persons who are HIV+. These trials include studies of those who are: highly-antiretroviral (ARV) experienced and for whom virologic suppression cannot be achieved and maintained;ARV-nai've, with advanced HIV disease and presenting for care with an opportunistic infection;co-infected with HIV and hepatitis virus;or at moderate-to-high risk of cardiovascular disease. Through the HPTN, the CPCRA CTU will contribute to trials examining both behavioral and therapeutic interventions with behavioral and biologic outcomes, seeking to reduce HIV transmission and HIV transmission-risk behavior. Targeted populations include those who are HIV+, as well as those who are HIV- and at-risk for seroconversion, such as injecting-drug and cocaine users and others at risk for seroconversion through sexual contact. The Executive Office of the CPCRA Clinical Trials Unit, located at the Veterans Affairs Medical Center in Washington DC, is an off-campus affiliate of the applicant institution, The George Washington University. The Principal Investigator and Executive Office staff provide oversight, central coordination, training and education, technical assistance, and regulatory support for its 137 clinical research sites, organized by region into 23 Site Coordinating Centers in the United States, Brazil, Canada, Peru, and South Africa. These sites have in care a cumulative, demographically diverse patient base of over 152,000 persons with HIV/AIDS. HIV is a major public health problem around the world. It is important to find better ways to use the medicines that we have to treat HIV, so that people who are infected can live longer and healthier lives. It is also important to find better ways to stop the spread of HIV by doing studies with people who have HIV infection and people who don't have HIV but who are at risk for getting HIV infection. PERFORMANCE SITE(S) (organization, city, state) The George Washington University;Washington, DC The Veterans Affairs Medical Center;Washington, DC Performance sites for Clinical Research are in five countries: 107 in the United States, 14 in Canada, 13 in Brazil, 2 in Peru, and 1 in South Africa. An itemization follows on continuation pages. PHS 398(Rev. 09/04) Page 2 'Form Page 2 RFA AI-05-002 "Units for HIV/AIDS Clinical Trials Networks" Principal Investigator: Gordin, Fred M. Performance Sites for INSIGHT Network Centra de Referenda e Treinamento DST/AIDS, Site # 001 Sao Paulo Site # 002 Hospital de Clfnicas de Porto Alegre Hospital Escola Sao Francisco de Assis/Projeto Site # 003 Praca Onze Site # 004 Hospital Nossa Senhora da Conceicao Site # 005 Hospital dos Servidores do Estado Site # 006 Institute A. Z. de Pesquisa e Ensino Site # 007 Institute de Infectologia Emilio Ribas Site # 008 WITHDRAWN Site # 009 Casa da AIDS, University of Sao Paulo Centra de Pesquisa Clinica do Hospital Site #010 Guilherme Alvaro Site # 01 1 Hospital Universitario Cassiano Antonio de Moraes Site #01 2 Hospital Universitario Professor Edgard Santos Site #01 3 Ambulatorio de Imunodeficiencias Secundarias Site #014 Unidade de Pesquisa Clinica (UNICAMP) Site #015 Centre Hospitaller de I'Universite Laval Site #016 Toronto Hospital Site #017 McMaster University Medical Centre Site #01 8 Queen Elizabeth II Health Sciences Centre Site #01 9 Centre Hospitaller Universitaire de Sherbrooke Site # 020 Montreal Chest Institute Site # 021 Windsor Regional Hospital Site # 022 St. Joseph's Health Centre Site # 023 Clinique Medicale L'Actuel Site # 024 Downtown Infectious Disease Clinic Clinique Medicale des Campus, Halles Site # 025 de Sainte-Foy Site # 026 Clinique du Quartier Latin Site #027 The Ottawa Hospital Site # 028 Centre Hospitalier de I'Universite de Montreal Site # 029 Hospital Nacional Edgardo Rebagliati Martins Site # 030 Hospital Nacional Guillermo Almenara Irigoyen Site # 031 Desmond Tutu HIV Centre Site # 032 Bronx-Lebanon Hospital Center Site # 033 Montefiore Medical Center Site # 034 Bronx Veterans Affairs Medical Center Site #035 Westchester Medical Center Site # 036 Klein, Slotten, &French Medical Associates Site # 037 Lakeshore Infectious Disease Associates Site # 038 University of Illinois at Chicago Site # 039 The University of Chicago Site # 040 Hennepin County Medical Center Site # 041 Aurora Medical Group RiverCenter City, State Sao Paulo, Brazil Porto Alegre, Brazil Rio de Janeiro, Brazil Porto Alegre, Brazil Rio de Janeiro, Brazil Curitiba, Brazil Sao Paulo, Brazil Sao Paulo, Brazil Sao Paulo, Brazil Santos, Brazil Vitoria, Brazil Salvador, Brazil Sao Paulo, Brazil Campinas, Brazil Sainte-Foy, Quebec, Canada Toronto, Ontario, Canada Hamilton, Ontario, Canada Halifax, Nova Scotia, Canada Fleurimont, Canada Montreal, Canada Windsor, ON, Canada London, ON, Canada Montreal, Quebec, Canada Vancouver, BC, Canada Ste-Foy, QC, Canada Montreal, Quebec, Canada Ottawa, ON, Canada Montreal, Quebec, Canada Lima, Peru Lima, Peru Cape Town, South Africa Bronx, New York Bronx, NY Bronx, New York Valhalla, NY Chicago, IL Chicago, IL Chicago, IL Chicago, IL Minneapolis, MN Milwaukee, Wl RFA AI-05-002 "Units for HIV/AIDS Clinical Trials Networks" Principal Investigator: Gordin, Fred M. Performance Sites for INSIGHT Network Site # 042 Medical College of Wisconsin Site # 043 Mayo Clinic, HIV Clinic Site # 044 Abbott Northwestern Hospital, Clinic 42 Site # 045 St John's Hospital and Medical Center University of Wisconsin Hospital and Clinics, Site # 046 HIV Care Program Site # 047 Denver Public Health Site # 048 Western Infectious Disease Consultants Site # 049 Denver Infectious Disease Consultants Site # 050 Kaiser Permanente, Colorado Region Site # 051 Veterans Affairs Medical Center Site # 052 Beacon Clinic Site # 053 McDowell Healthcare Center Site # 054 University of Oklahoma Health Sciences Center University of North Texas, Tarrant County Site # 055 Health Department Site # 056 University of Kansas School of Medicine North Broward Hospital District, Comprehensive Site # 057 Care Center Site # 058 University of Florida, Jacksonville Site # 059 HUG-Me Program, Orlando Site # 060 University of Miami Site # 061 Harlem Family Center, Harlem Hospital Center Site #062 Jacob! Medical Center Site # 063 St. Vincent's Medical Center Site # 064 Metropolitan Hospital Center Site # 065 Lincoln Medical &Mental Health Center Site # 066 New Jersey Medical School, UMDNJ Site # 067 Henry Ford Hospital Site # 068 Ingham Regional Medical Center Site # 069 University of Michigan Site # 070 Thomas Street Clinic, Baylor College of Medicine Thomas Street Clinic, The University of Texas Site # 071 Health Science Center Site # 072 Michael E DeBakey Veterans Affairs Medical Center University of Texas Clinical Research Center, Site # 073 Memorial Hermann Hospital University of Texas Health Science Center Site # 074 at San Antonio Veterans Affairs Greater Los Angeles Site # 075 Healthcare System Site # 076 LA Gay &Lesbian Community Center Site # 077 AltaMed Health Services Site # 078 El Rio Community Health Care Center Site # 079 Our Lady of the Lake Regional Medical Center City, State Milwaukee, Wl Rochester, MN Minneapolis, MN Detroit, Ml Madison, Wl Denver, CO Wheatridge, CO Denver, CO Denver, CO Denver, CO Boulder, Colorado Phoenix, AZ Oklahoma City, OK Fort Worth, TX Wichita, KS Ft. Lauderdale, FL Jacksonville, FL Orlando, FL Miami, FL New York, NY Bronx, NY New York, NY New York, NY Bronx, NY Newark, NJ Detroit, Ml Lansing, Ml Ann Arbor, Ml Houston, TX Houston, TX Houston, TX Houston, TX San Antonio, TX Los Angeles, CA Los Angeles, CA Los Angeles, CA Tucson, AZ Baton Rouge, LA RFA AI-05-002 "Units for HIV/AIDS Clinical Trials Networks" Principal Investigator: Gordin, Fred M. Performance Sites for INSIGHT Network Site # 080 Medical Center of Louisiana at New Orleans Site # 081 Tulane University Health Sciences Center Site # 082 Veterans Affairs Medical Center Site # 083 Earl K Long Medical Center Site # 084 University of Mississippi Medical Center Site # 085 Center for Prevention and Treatment of Infections Site # 086 Yale University School of Medicine, AIDS Program Site # 087 Hospital of St Raphael Site # 088 Community Research Initiative of New England-Boston Community Research Initiative of New England- Site # 089 Springfield Site # 090 Veterans Affairs Connecticut Healthcare System Site # 091 Waterbury Hospital Site # 092 St. Michael's Medical Center Site # 093 Raritan Bay Medical Center Site # 094 ID Care, Hillsborough Site # 095 Infectious Disease Specialists of New Jersey Site #096 St Joseph's Hospital and Medical Center Site # 097 Jeffrey Bomser Clinic Site # 098 ID Care, Randolph Site # 099 Oregon Health and Science University Site #100 Legacy Clinic Good Samaritan Site #101 Kaiser Permanente Immune Deficiency Clinic Site #102 Providence Portland Medical Center Site #103 Multnomah County Health Department Site #104 Legacy Clinic Emanuel Site #105 Family Medicine Residency of Idaho Site #106 Virginia Commonwealth University Medical Center Site #107 McGuire Veterans Affairs Medical Center Site #108 Cross Over Health Center Site #109 Dr. Ronald Artz Site #110 South Richmond Health Care Center Site #111 Center for Comprehensive Care of Immune Deficiency Site #112 Vernon J Harris Health Center Site #113 Petersburg Health Care Center Site #114 Infectious Disease Associates of Central Virginia Site #115 Infectious Disease Associates Site #116 San Francisco General Hospital Site #117 45 Castro Medical Center Site #118 Castro Mission Health Center Site #119 Tom Steele Clinic Site #120 Alta Bates Medical Center Site #121 Primary Care Practice of Dr. Robert Scott Positive Health Practice at University of California Site #122 San Francisco City, State New Orleans, LA New Orleans, LA New Orleans, LA Baton Rouge, LA Jackson, MS Pensacola, FL New Haven, CT New Haven, CT Boston, MA Springfield, MA West Haven, CT Waterbury, CT Newark, NJ Perth Amboy, NJ Hillsborough, NJ Union, NJ Paterson, NJ Newark, NJ Randolph, NJ Portland, OR Portland, OR Portland, OR Portland, OR Portland, OR Portland, OR Boise, ID Richmond, VA Richmond, VA Richmond, VA Mechanicsville, VA Richmond, VA Norfolk, VA Richmond, VA Petersburg, VA Lynchburg, VA Fredericksburg, VA San Francisco, CA San Francisco, CA San Francisco, CA Mill Valley, CA Berkeley, CA Oakland, CA San Francisco, CA RFA AI-05-002 "Units for HIV/AIDS Clinical Trials Networks" Principal Investigator: Gordin, Fred M. Performance Sites for INSIGHT Network Site #123 Veterans Affairs Medical Center Site #124 University Medical Center Site #125 Cooper Hospital/University Medical Center Site #126 Jersey Shore University Medical Center Site #127 Early Intervention Program at Kennedy Hospital Site #128 South Jersey Infectious Disease Site #129 Penn Community Infectious Diseases Site #130 Temple University Comprehensive HIV Program Site #131 Veterans Affairs Medical Center Site #132 Christiana Care HIV Program at Wilmington Annex Site #133 Miami Veterans Affairs Medical Center Christiana Care HIV Program at Georgetown Site #134 Wellness Clinic Site #135 South Texas Veterans Health Care System Site #136 George Washington University Medical Center Site #137 Wayne State University / Detroit Medical Center Site #138 McAuley Health Center City, State San Francisco, CA Fresno, CA Camden, NJ Neptune, NJ Voorhees, NJ Somers Point, NJ Philadelphia, PA Philadelphia, PA Washington, DC Wilmington, DE Miami, FL Georgetown, DE San Antonio, TX Washington, DC Detroit, Michigan Grand Rapids, Michigan Performance Sites for HIV Prevention Trials Network Hospital Escola Sao Francisco de Assis/Projeto Site # 003 Praca Onze Site # 007 Institute de Infectologia Emilio Ribas Site # 01 1 Hospital Universitario Cassiano Antonio de Moraes Site #012 Hospital Universitario Professor Edgard Santos Site #01 3 Ambulatorio de Imunodeficiencias Secundarias Site # 032 Bronx-Lebanon Hospital Center Site #047 Denver Public Health Site # 067 Henry Ford Hospital Site # 086 Yale University School of Medicine, AIDS Program Site # 094 ID Care, Hillsborough Site #097 Jeffrey Bomser Clinic Site # 099 Oregon Health and Science University Site #100 Legacy Clinic Good Samaritan Site #106 Virginia Commonwealth University Medical Center Site #125 Cooper Hospital/University Medical Center Site #130 Temple University Comprehensive HIV Program Site #137 Wayne State University / Detroit Medical Center City, State Rio de Janeiro, Brazil Sao Paulo, Brazil Vitoria, Brazil Salvador, Brazil Sao Paulo, Brazil Bronx, New York Denver, CO Detroit, Ml New Haven, CT Hillsborough, NJ Newark, NJ Portland, OR Portland, OR Richmond, VA Camden, NJ Philadelphia, PA Detroit, Michigan RFAAI-05-002 "Units for HIV/AIDS Clinical Trials Networks" Principal Investigator: Gordin, Fred M. KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Role on Project Organization Gordin, Fred M Principal Investigator Abrams, Donald Co-Pi Arduino, Roberto..... Co-Pi Baxter, John Co-Pi Conn, David Co-Pi Crane, Lawrence Co-Pi El-Sadr, Wafaa Co-Pi Friedland, Gerald Co-Pi Goetz, Matthew Co-Pi Kolber, Michael Co-Pi La Rosa, Alberto Co-Pi Labriola, Ann Co-Pi Luskin-Hawk, Roberta Co-Pi Markowitz, Norman Co-Pi Mushatt, David Co-Pi Nixon, Daniel Co-Pi Pereira Junior, Luiz Carlos Co-Pi Perez, George Co-Pi '. Sampson, James Co-Pi Schechter, Mauro Co-Pi Telzak, Edward Co-Pi Temesgen, Zelalem Co-Pi Wood, Robin Co-Pi Zarowny, Donald Co-Pi Finley, Elizabeth Executive Coordinator Mol, Laura Administrative Officer Turner, Melissa M CAB Liaison Vjecha, Michael J.. Project Director OTHER SIGNIFICANT CONTRIBUTORS: n/a Human Embryonic Stem Cells x No Q Yes CPCRA Clinical Trials Unit San Francisco Site Coordinating Center Houston SCC South Jersey SCC Denver SCC Wayne State SCC Harlem SCC New England SCC Los Angeles SCC Florida SCC Peru SCC Washington SCC Chicago SCC Henry Ford SCC Louisiana SCC Richmond SCC Brazil, Sao Paulo SCC North Jersey SCC Portland SCC Brazil, Rio SCC Bronx SCC CORNET SCC South Africa SCC Canada SCC CPCRA Executive Office CPCRA Executive Office CPCRA Executive Office CPCRA Executive Office If the proposed project Involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list: http://stemcells.nih.qov/reqistry/index.asp. Use continuation pages as needed. If a specific line cannot be referencedat this time, include a statement that one from the Registry will be used. Cell Line n/a Disclosure Permission Statement. Applicable to SBIR/STTR Only. SeeSBIR/STTR instructions. C] Yes X No PHS 398 (Rev. 09/04) Page Form Page 2-continued 7 CPCRA Clinical Trials Unit Principal Investigator: Gordin, Fred M. 3. Table of Contents 8